Current challenges and opportunities in nonclinical safety testing of biologics.
Current challenges and opportunities in nonclinical safety testing of biologics.
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当前生物制品非临床安全性测试的挑战和机遇。
DOI：
10.1016/j.drudis.2013.08.003
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发表时间：
2013
影响因子：
7.4
通讯作者：
T. Singer
中科院分区：
文献类型：
--
作者：
S. Kronenberg;A. Baumann;L. de Haan;H. Hinton;J. Moggs;F. Theil;Ian Wakefield;T. Singer
重点介绍了新生物学模式复杂性的当前非临床挑战。关于聚乙二醇化蛋白、转基因小鼠和意外PK的案例。深入了解多特异性靶向和免疫安全性的新发展。新生物制剂实体的非临床安全性测试代表了其自身在药物开发中的挑战和机遇。最近在第二届BioSafe欧洲会员大会上讨论了这一领域的热点问题。在这篇专题文章中，讨论了围绕聚乙二醇化治疗蛋白的使用，选择食蟹猴作为临床前物种，生物制剂的意外药代动力学及其安全性影响的挑战。此外，生物制品的免疫安全性测试，使用转基因小鼠模型和PK和安全性的影响，多特异性靶向方法的新发展进行了讨论。总的来说，新的生物学模式和形式的日益复杂性保证了量身定制的非临床开发策略和实验测试。
HighlightsCurrent nonclinical challenges on the complexity of new biologic modalities.Case examples on PEGylated proteins, transgenic mice and unexpected PK.Insights into multispecific targeting and new developments in immunosafety.Nonclinical safety testing of new biotherapeutic entities represents its own challenges and opportunities in drug development. Hot topics in this field have been discussed recently at the 2nd Annual BioSafe European General Membership Meeting. In this feature article, discussions on the challenges surrounding the use of PEGylated therapeutic proteins, selection of cynomolgus monkey as preclinical species, unexpected pharmacokinetics of biologics and the safety implications thereof are summarized. In addition, new developments in immunosafety testing of biologics, the use of transgenic mouse models and PK and safety implications of multispecific targeting approaches are discussed. Overall, the increasing complexity of new biologic modalities and formats warrants tailor-made nonclinical development strategies and experimental testing.
影响因子：
15.9
作者：
Miyajima, I;Dombrowicz, D;Galli, SJ
通讯作者：
Galli, SJ